Trial document





This trial has been registered retrospectively.
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  DRKS00003694

Trial Description

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Title

Geriatric Assessment in patients older than 60 years with hematological malignancies undergoing allogeneic stem cell transplantation

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Trial Acronym

none

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URL of the Trial

[---]*

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Brief Summary in Lay Language

It is one of the most difficult task for the leukemia physician to delineate the individually best treatment option for an older patient affected by acute leukemia. Treatment can range from sole best supportive care, low dose treatment or experimental therapies to high dose chemotherapy followed by allogeneic stem cell transplantation. Our aim is to investigate whether prognostic parameters can be identified with a comprehensive geriatric assessment in elderly patients undergoing allogeneic stem cell transplantation that can help in the future to identify patients that will benefit from this intensive treatment. Despite reduced intensity conditioning (RIC) which results in a markedly reduced number of treatment realted complications and deaths, allogeneic stem cell transplantation still poses relevant risks that withhold many physicians from recommending this - potentially curative - treatment approach from elderly patients.

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Brief Summary in Scientific Language

Prospective single-center observational study investigating the prognostic value of parameters of a Geriatric Assessment.

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Organizational Data

  •   DRKS00003694
  •   2012/04/30
  •   [---]*
  •   yes
  •   Approved
  •   371/07, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C92.0 -  Acute myeloid leukaemia
  •   D46 -  Myelodysplastic syndromes
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Interventions/Observational Groups

  •   There is no intervenention. The Geriatric Assessment takes about 45 minutes and consists of a number of validated tests and questionnaires. It will be performed on day 0, 30, and 90.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Progression free survival (PFS).
Hazard ratios for PFS will be calculated

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Secondary Outcome

Overall survival

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/11/01
  •   110
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   60   Years
  •   no maximum age
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Additional Inclusion Criteria

written informed consent, higher risk MDS, AML, anticipated allogeneic stem cell transplantation, mental capacity top fill out questionnaires and obey simple orders. Regional proxicity for regular follow-up

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Exclusion Criteria

other malignancies not in remission, inability to fill out german questionnaires, lack of informed consent. Trial participation in a medical treatment study is NOT an exclusion criterion.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Hämatologie, Onkologie Med I
    • Mr.  Prof. Dr.  Jürgen  Finke 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Hämatologie/Onkologie Med I Uniklinik Freiburg
    • Ms.  Dr.  Barbara  Deschler 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Medizinische Unviversitätklinik Freiburg
    • Ms.  Dr.  Barbara  Deschler 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Krebshilfe e.V.
    • Buschstr. 32
    • 53113  Bonn
    • Germany
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    •   Telefon: 02 28/7 29 90–0
    •   Telefax: 02 28/7 29 90–11
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/09/01
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.